Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to test the identity of each batch of incoming production material and appropriately qualify suppliers to rely upon their Certificate of Analysis.
Passage 2Failure to document, explain, and investigate any deviation from established procedures.
Passage 3Your firm failed to investigate deviations from your quality specifications for your repackaged drugs. For example, your firm failed to adequately investigate observed contamination of particulates in numerous packaged drugs. According to your production records, the contamination included various unidentified colored particulates, reports of insects, hair, and fibers in your repackaged containers of glycerin, propylene glycol, and **(b)(4)**.